Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00630032
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.
Secondary
* To compare the 5-year distant metastasis-free survival.
* To compare the 5-year event-free survival.
* To compare the 5-year overall survival.
* To compare the safety profiles for the two chemotherapy regimens.
* To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens.
* To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses).
* To compare the cost-effectiveness of these 2 regimens.
* To compare the quality-of-life of patients treated with these 2 regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor \[ER\] positive). Patients are randomized to 1 of 2 treatment arms.
* Docetaxel Arm: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6.
* Ixabepilone Arm: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also complete a quality of life questionnaire periodically.
After completion of study treatment, patients are followed periodically for up to 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 762
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel cyclophosphamide 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel Docetaxel 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel epirubicin hydrochloride 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Docetaxel fluorouracil 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks) Ixabepilone cyclophosphamide 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone epirubicin hydrochloride 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone fluorouracil 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks); Ixabepilone ixabepilone 3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
- Primary Outcome Measures
Name Time Method Percentage of Participants With Disease-free Survival (DFS) At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Number of Disease-free Survival Events for Triple-negative Subgroup At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only.
Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup At 5 years DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only.
Number of Distant Metastasis-free Survival Events for the Whole Population At 5 years The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Overall Survival At 5 years The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Number of Event-free Survival At 5 years The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.
Trial Locations
- Locations (85)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Centre Hospitalier d'Auxerre
🇫🇷Auxerre, France
Centre Hospitalier de Fleyriat
🇫🇷Bourg-En-Bresse, France
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Clinique Claude Bernard
🇫🇷Ermont, France
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Centre Hospitalier Hutois
🇧🇪Huy, Belgium
Clinique Universitaire De Mont-Godinne
🇧🇪Yvoir, Belgium
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Institut Sainte Catherine
🇫🇷Avignon, France
Centre Paul Papin
🇫🇷Angers, France
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Centre Hospitalier Regional de Chambery
🇫🇷Chambery, France
Hopital Jean Monnet
🇫🇷Epinal, France
Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Cazk Groeninghe - Campus Maria's Voorzienigheid
🇧🇪Kortrijk, Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
🇧🇪Mons, Belgium
Roger Maris Cancer Center at MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Hospitalier de Blois
🇫🇷Blois, France
Centre Hospitalier de Dax
🇫🇷Dax, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Curie Hopital
🇫🇷Paris, France
Polyclinique Francheville
🇫🇷Perigueux, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier de Chateaubriant
🇫🇷Chateaubriant cedex, France
Clinique des Cedres
🇫🇷Cornebarrieu, France
Hopital Intercommunal De Creteil
🇫🇷Creteil, France
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre de Radiotherapie et Oncologie Saint-Faron
🇫🇷Mareuil Les Meaux, France
Centre Hospitalier de Montlucon
🇫🇷Montlucon, France
Hopital Saint Michel
🇫🇷Paris, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
🇫🇷Montfermeil, France
Hopital Clinique Claude Bernard
🇫🇷Metz, France
Polyclinique De Courlancy
🇫🇷Reims, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Hospitalier de Rodez
🇫🇷Rodez, France
Centre d'Oncologie Saint-Yves
🇫🇷Vannes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Oncology Associates at Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Centre de Sante des Fagnes
🇧🇪Chimay, Belgium
Clinique Saint-Pierre
🇧🇪Ottignies, Belgium
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CHU Hopital A. Morvan
🇫🇷Brest, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
CMC Les Ormeaux
🇫🇷Le Havre, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Hospitalier
🇫🇷Mulhouse, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Clinique du Pont de Chaume
🇫🇷Montauban, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Clinique D'Occitanie
🇫🇷Muret, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Clinique De Valdegour
🇫🇷Nimes, France
Centre Hospitalier - Pau
🇫🇷Pau, France
Centre Hospitalier de Perpignan
🇫🇷Perpignan, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut Jean Godinot
🇫🇷Reims, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Clinique de l'Union
🇫🇷Saint Jean, France
Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez, France
Centre Regional Rene Gauducheau
🇫🇷Saint-Herblain, France
Polyclinique de L'Ormeau
🇫🇷Tarbes, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Clinique Du Parc
🇫🇷Toulouse, France
Centre Hospitalier Regional Metz Thionville
🇫🇷Thionville, France
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States